MDA Registration Support in Malaysia
Medical Device Registration
Registering a medical device in Malaysia requires the correct classification, documentation and regulatory submission process.
T T Medical provides comprehensive medical device registration services in Malaysia, helping manufacturers navigate MDA requirements from initial regulatory assessment through registration.
Malaysia Regulatory Registration
MDA Medical Device Registration in Malaysia
Medical devices intended to be imported, exported or placed on the Malaysian market are subject to registration requirements under the Medical Device Act 2012 (Act 737). Our medical device registration service supports local and international manufacturers in understanding the applicable requirements, preparing the necessary documentation and managing their application with the Medical Device Authority, whether registering a new device or expanding an existing product portfolio.
Our Medical Device Registration Support
Device Classification & Grouping
Determine the appropriate medical device classification and grouping based on intended purpose and MDA requirements.
Regulatory Documentation
Review and prepare the documentation required to support your medical device registration application.
Conformity Assessment Support
Coordinate and support the applicable conformity assessment process where required before registration.
MDA Registration Submission
Prepare, submit and manage the application while supporting responses to regulatory queries throughout the registration process.
Simple Steps to Registration
Our MDA Registration Process
01
Regulatory Assessment
We review your medical device, intended use and available regulatory documentation.
02
Classification & Documentation
Our team determines the appropriate regulatory pathway and prepares the required registration documentation.
03
Submission & Coordination
We support the conformity assessment where applicable and manage the submission to the Medical Device Authority.
04
Registration Support
We follow the application through the regulatory process and assist with the required responses and registration matters.
Expert Regulatory Guidance
Need Regulatory Support in Malaysia?
Speak with our experienced regulatory team to identify the right registration or representation service for your medical device and receive practical guidance throughout the Malaysian regulatory process.
